Roche Diagnostics Corp. - FDA 510(k) Cleared Devices

Cleared Oct 05, 2010

ELECSYS CA 19-9 CALCHECK 5

K101365 · JJX

Immunology · 141d

Cleared Mar 18, 2009

C-REACTIVE PROTEIN (LATEX)

K083444 · DCN

Immunology · 117d

Cleared Jul 28, 2008

ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB

K080092 · JZO

Immunology · 196d

Cleared Mar 06, 2008

ROCHE-CREACTIVE PROTEIN (LATEX)

K073277 · DCN

Immunology · 106d

Cleared Jan 31, 2007

CERULOPLASMIN, MODEL 2055953

K062114 · CHN

Immunology · 191d

Cleared Feb 07, 2006

ROCHE ELECSYS ANTI-TG

K053426 · JZO

Immunology · 61d

Cleared Aug 04, 2005

ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO

K051890 · JZO

Immunology · 23d

Cleared Jul 06, 2005

ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET

K050231 · JIT

Immunology · 161d

Cleared Jul 06, 2005

ELECSYS CA 19-9 CALCHECK

K051185 · JJY

Immunology · 58d

Cleared Apr 25, 2005

ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR

K050387 · JJY

Immunology · 69d

Cleared Feb 08, 2005

TINA-QUANT IGG GEN.2

K050113 · DEW

Immunology · 21d

Cleared Nov 23, 2004

ROCHE DIAGNOSTICS ELECSYS AFP CALSET II

K043095 · JIT

Immunology · 14d